The GP's Role in Cancer Rehabilitation: a Randomised, Controlled Study.

HRQOL (Health Related Quality Of Life) Clinical Trial

Official title:

The GP's Role in Cancer Rehabilitation: a Randomised, Controlled Study.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01021371
• Other study ID #: RCT Cancer rehab
• Status: Completed
• Phase: Phase 0
• First received: November 27, 2009
• Last updated: October 26, 2016
• Start date: May 2008
• Est. completion date: February 2009

Study information

• Verified date: October 2016
• Source: University of Southern Denmark
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Dataprotection Agency
• Study type: Interventional

Clinical Trial Summary

The aim of this study is to investigate the impact of a joint effort towards intensifying the collaboration and communication between hospital and general practice.

Description:

Background

In recent years an increasing focus has been on the unfulfilled needs of cancer patients for an individual rehabilitation taking into consideration the physical, psychological, social, economic, as well as work-related consequences of the cancer disease. Furthermore, there is a great need for ongoing adjustments of the organisation and procurement of rehabilitation offers and for optimizing the continuity of care, especially regarding transfer between sectors.

Research question

The aim of this study is to investigate whether a joint effort towards intensifying the collaboration and communication between hospital and general practice and encouraging the GP to take an active and prominent part in the rehabilitation process on actual patients has any effect on:

1. Health Related Quality of Life

2. The rehabilitation of cancer patients

3. The experience of continuity of care among cancer patients

4. How the GP act with regard to rehabilitation among cancer patients

Material and methods

The study uses a randomised, controlled design and is carried out as a PhD project. At Vejle Hospital approximately 1000 patients (500 in the intervention group and 500 in the control group) was included at the initiation of treatment. The intervention consists of an extended information routine from hospital to GP based on individual interviews with the patients in the intervention group and a specific encouragement of the patients' GP to play a proactive role in the patients' rehabilitation course. The individual needs concerning the different types of consequences of the disease and following rehabilitation needs will be brought into focus. The data will be obtained from public health registers and questionnaires to patients 6 and 14 months after the time of diagnosis (measuring Health Related Quality of Life, satisfaction with and use of rehabilitation activities, perceived continuity of care and satisfaction with their GP) and to GPs after 12 months (measuring satisfaction with the information from the hospital and activities to meet the patients' rehabilitation needs).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 959
• Est. completion date: February 2009
• Est. primary completion date: February 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• All new cancer patients receiving treatment, be it surgery, chemotherapy or radiation, at Vejle Hospital in the period of inclusion.

Exclusion Criteria:

• Patients diagnosed more than 3 months earlier

• Patients younger than 18

• Patients with non-melanoma skin cancer.

• Patients with recurrence of a previous cancer

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• HRQOL (Health Related Quality Of Life)

Intervention

Behavioral:
• Two step intervention including patient interview followed by an extended information routine to the patients' GP about the patients' rehabilitation needs
The intervention consists of an extended information routine from hospital to GP based on individual interviews with the patients in the intervention group and a specific encouragement of the patients' GP to play a proactive role in the patients' rehabilitation course. The individual needs concerning the different types of consequences of the disease and following rehabilitation needs will be brought into focus. The control group is assigned to usual procedures.

Locations

Country	Name	City	State
Denmark	Reserch Unit of General Practice, Institute of Public Health, University of Southern Denmark	Odense

Sponsors (3)

Lead Sponsor	Collaborator
University of Southern Denmark	Vejle Hospital, Vejle Kommune

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Health Related Quality of Life		14 months	No
Secondary	How the GP act with regard to rehabilitation among cancer patients		14 months	No